Metastatic Breast Cancer or Metastatic Colorectal CancerPhase 1NCT01846650
A Bioequivalence Study of Capecitabine Tablets
A Phase 1 study testing Capecitabine tablets and XELODA in people with Metastatic Breast Cancer or Metastatic Colorectal Cancer, run by Chia Tai Tianqing Pharmaceutical Group Co., Ltd. at 1 site in China.
Trial summary
1. purpose: To conduct the relative bioavalability study of Capecitabine tablets 500 mg (Jiangsu Chia-Tai Tianqing Pharmacy Co. Ltd.) versus XELODA® 500 mg tablets (Manufactured by Roche Pharma AG) 2. Experimental Design： Two-period crossover design 3. Test drug: Capecitabine tablets Reference drug: XELODA 4. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Metastatic Breast Cancer or Metastatic Colorectal Cancer
- What is being tested?
- Capecitabine tablets and XELODA
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteChina
- Study dates
- Dec 2012to Jun 2013
- Phase
- Phase 1
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients must have histopathologically /cytologically confirmed breast cancer or colorectal cancer，without chemotherapy or only adjuvant chemotherapy, and had previously received one or two standard chemotherapy regimens for patients;
- Age: 18-70 years, gender: both，BMI≥17，Eastern Cooperative Oncology Group (ECOG) performance status：0-2，Life expectancy greater than 3 months;
- Patients must have normal bone marrow function, liver and kidney function; adequate organ function in the last 1 week, meeting the following: ANC≥1.5×109/L，PLT≥80×109/L, Total bilirubin≤1.5×the upper limit of normal, ALT,AST≤2.5×the upper limit of normal, creatinine≤1.5×the institutional upper limit of normal.
- Patients who has retreatment could be enrolled at least 4 weeks after the last chemotherapy and radiotherapy.
- Patients must volunteer to participate and sign informed consent form.
Who cannot join
- Suffering from heart, liver, kidney disease or severe acute and Organ invasion disease;
- Prior unanticipated severe reaction to fluoropyrimidine therapy, or known sensitivity to 5-fluorouracil, or known DPD (Dihydropyrimidine Dehydrogenase) deficiency.
- Pregnant or breast-feeding female
- Only bone metastasis lesions, no other measurable lesions
- Known brain metastasis or history of organ transplantation
- Have long-term systemic steroid therapy
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- Serious diseases of vital organs; other malignancies which is not cure
- Use of chemotherapy in the last 4 weeks
- History of drug/alcohol addiction or a positive hepatitis screen including hepatitis B surface antigen, HCV or HAV (IgM) antibodies
- Patient having abnormal serum calcium level at screening visit which as judged by Investigator could lead to safety risk to the patient upon participation in the trial or could interfere with the conduct of the trial.
- Pre-existing motor or sensory neurotoxicity of a severity grade 2 by NCI CTCAE criteria or known, existing uncontrolled coagulopathy.
- Subjects are thought unsuitable for the study by investigators;
- Inability to comply with protocol or study procedures in the opinion of the investigator;
Trial locations and contacts
1 site in 1 country.
China1 site
First Affiliated Hospital of Fourth Military Medical University
Xi’an, Shanxi
About this study
Official title: A Bioequivalence Study of Capecitabine Tablets in Patients of Locally Advanced or Metastatic Breast Cancer or Metastatic Colorectal Cancer
- purpose: To conduct the relative bioavalability study of Capecitabine tablets 500 mg (Jiangsu Chia-Tai Tianqing Pharmacy Co. Ltd.) versus XELODA® 500 mg tablets (Manufactured by Roche Pharma AG)
- Experimental Design： Two-period crossover design
- Test drug: Capecitabine tablets Reference drug: XELODA
- Sample size：24
- Being tested
- Capecitabine tablets, XELODA
- Medical subject headings
- Breast Neoplasms, Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Capecitabine tabletsDrug
Single oral Capecitabine tablets 2000mg qd
XELODADrug
Single oral XELODA 2000mg qd
| Study group | Role | What they receive |
|---|---|---|
| Capecitabine tablets | Experimental | Single oral Capecitabine tablets 2000mg qd Receives: Drug: Capecitabine tablets |
| XELODA | Active comparator | Single oral XELODA 2000mg qd Receives: Drug: XELODA |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area Under Curve (AUC)
Measured: predose, 0.33,0.67，1,1.5,2，2.5，3,4，5,6，8,hours post-dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2013 (estimated)
- Study startDec 2012
- Primary completionJun 2013
- Study completionJun 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic Breast Cancer or Metastatic Colorectal CancerStudies of the same condition, open and under way.
- More trials run by Chia Tai Tianqing Pharmaceutical Group Co., Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Wen Ai dong, doctor, Principal investigator, First Affiliated Hospital of Fourth Military Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01846650
- Sponsor's protocol ID
- KPTB-1.1
- Status last verified
- Sep 2013
- First submitted
- 1 May 2013
- Last updated
- 1 Oct 2013
- Results posted
- No
- Data monitoring committee
- Yes